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OpenTrials
Completed

NCT Number: NCT03367247

BOLSTER: Building Out Lifelines for Safety, Trust, Empowerment and Renewal

This research study is evaluating a new intervention, BOLSTER, which was designed to provide more support for patients with gynecologic and gastrointestinal cancers and their caregivers after a hospitalization.

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Key information

About this study

Hospitalizations can be difficult for patients with cancer, especially when they are transitioning home. Patients and caregivers are often expected to perform complex medical and nursing tasks with little or no preparation. Patients and caregivers report high levels of unmet needs for information about how best to manage symptoms and new medical procedures (such as managing new tubes, lines or drains).

The study team has developed a research project which aims to address these needs. If a patient agrees to participate in the study, she will take part in a program called BOLSTER (Building Out Lifelines for Safety, Trust, Empowerment and Renewal). BOLSTER will provide patients and caregivers with education and skills training, symptom management, and support across care settings.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patient inclusion criteria

  • Adults (≥18 years old);
  • GYN or GI cancers receiving anti-neoplastic therapy;
  • Hospitalized, recently hospitalized (i.e. within the first 2 visits after a hospitalization), or recent outpatient placement of tube, line, or drain (e.g. PleurX catheter);
  • Plan to receive ongoing care at DFCI;
  • Willingness to be audio taped for the study (for monitoring of study fidelity).
  • Have complex care needs (e.g. an ostomy, ileostomy, a gastric tube, percutaneous nephrostomy tubes, a PleurX catheter, or need for total parenteral nutrition)

Patient exclusion criteria

  • Unable to read and respond to questions in English;
  • Cognitive impairment;
  • Unable to complete the baseline interview;
  • Plan for immediate hospice referral

Caregiver inclusion criteria

  • Adults (≥18 years old);
  • Family member or friend of an eligible patient;
  • Willingness to be audio taped for the study (for monitoring of study fidelity);
  • Willingness to participate in study visits

Caregiver exclusion criteria:

  • Unable to read and respond to questions in English,
  • Cognitive impairment
  • Unable to complete the baseline interview

Treatment and study plan

BOLSTER

Behavioral

BOLSTER provides patients and caregivers with education and skills training, symptom management, and support across care settings over a four-week period.

Enhanced Discharge Planning (EDP)

Other

EDP provides patients and caregivers a single session of education and skills training, symptom management, and support.

Primary outcomes

  1. Feasibility of the BOLSTER Intervention

    Time frame: 1 month

    ≥50% consent-to-approach ratio

Secondary outcomes

  1. Acceptability of the BOLSTER Intervention

    Time frame: 3 months

    ≥70% participants "agree" or "strongly agree" that they would recommend BOLSTER to other patients; and ≥70% participants "agreed or "strongly agreed" that they were satisfied with the BOLSTER intervention. Note that this measure only includes data from the RCT portion of the study, as the Phases 1a and 1b were designed to refine the intervention.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Dec 8, 2017
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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